ALABAMA BOARD OF MEDICAL EXAMINERS ADMINISTRATIVE CODE CHAPTER 540-X-8 ADVANCED PRACTICE NURSES: COLLABORATIVE PRACTICE TABLE OF CONTENTS

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1 Medical Examiners Chapter 540-X-8 ALABAMA BOARD OF MEDICAL EXAMINERS ADMINISTRATIVE CODE CHAPTER 540-X-8 ADVANCED PRACTICE NURSES: COLLABORATIVE PRACTICE TABLE OF CONTENTS 540-X X X X X X X X X X X X X X X Definitions Terms And Functions Of The Joint Committee Qualifications For Approval To Practice As A Certified Nurse Practitioner Qualifications For Physicians In Collaborative Practice With Certified Registered Nurse Practitioners Application And Approval To Practice As A Certified Registered Nurse Practitioner Authorization For Practice As A Certified Registered Nurse Practitioner Temporary Approval To Practice As A Certified Registered Nurse Practitioner Requirements For Collaborative Practice By Physicians And Certified Registered Nurse Practitioners Standards Of Practice For Certified Registered Nurse Practitioners Functions And Activities Of Certified Registered Nurse Practitioners Prescriptions And Medication Orders By Certified Registered Nurse Practitioners Limitations Upon Utilization Of Certified Registered Nurse Practitioners Grounds For Denial/Withdrawal Of Approval Of The Certified Registered Nurse Practitioner and Collaborating Physician Denial, Suspension And Revocation Of License Grounds For Termination Of Approval Of A Collaborative Practice Physicians And Certified Registered Nurse Practitioners Supp. 3/31/17 8-1

2 Chapter 540-X-8 Medical Examiner 540-X X X X X X X X X X X X X X X Termination Of Approval Of A Collaborative Practice Physicians And Certified Registered Nurse Practitioners Qualifications For Approval As A Certified Nurse Midwife Qualifications For Physicians In Collaborative Practice With Certified Nurse Midwives Application For Approval To Practice As A Certified Nurse Midwife Authorization For Practice As A Certified Nurse Midwife Temporary Approval To Practice As A Certified Nurse Midwife Requirements For Collaborative Practice By Physicians And Certified Nurse Midwives Standards Of Practice Of Certified Nurse Midwives Functions And Activities Of Certified Nurse Midwives Prescriptions And Medication Orders By A Certified Nurse Midwife Limitations Upon Utilization Of Certified Nurse Midwives Grounds For Denial/Withdrawal Of Approval Of The Certified Nurse Midwife And Collaborating Physician Denial, Suspension And Revocation Of License Grounds For Termination Of Approval Of A Collaborative Practice Physicians And Certified Nurse Midwives Termination Of Approval Of A Collaborative Practice Physicians And Certified Nurse Midwives 540-X Definitions. The following definitions will apply to these rules: (1) BOARD OF MEDICAL EXAMINERS. The State Board Of Medical Examiners established pursuant to Code of Ala. 1975, (2) BOARD OF NURSING. The Board of Nursing established under Code of Ala. 1975, Supp. 3/31/17 8-2

3 Medical Examiners Chapter 540-X-8 (3) ADVANCED PRACTICE NURSE. A registered nurse who has gained additional knowledge and skills through successful completion of an organized program of nursing education that prepares nurse for advanced practice roles and has been approved by the Board of Nursing to engage in the practice of advanced practice nursing. Two categories of advanced practice nurses are subject to the requirements of collaborative practice: (a) (b) Certified registered nurse practitioners (CRNP) Certified nurse midwives (CNM) (4) ADVANCED PRACTICE NURSING COLLABORATIVE PRACTICE. The delivery of health care services by registered nurses who have gained additional knowledge and skills through successful completion of an organized program of nursing education that prepares nurses for advanced practice roles as certified registered nurse practitioners or certified nurse midwives: (a) Practice as a certified registered nurse practitioner (CRNP) is the performance of nursing skills by a registered nurse who has demonstrated by certification advanced knowledge and skills in the delivery of nursing services within a health care system that provides for consultation, collaborative management or referral as indicated by the health status of the client. (b) Practice as a certified nurse midwife (CNM) is the performance of nursing skills by a registered nurse who has demonstrated by certification advanced knowledge and skills relative to the management of women s health care focusing on pregnancy, childbirth, the post-partum period, care of the newborn, family planning and gynecological needs of women, within a health care system that provides for consultation, collaborative management or referral as indicated by the health status of the client. (5) COLLABORATION. A formal relationship between one or more certified registered nurse practitioners or certified nurse midwives and a physician or physicians under which these nurses may engage in advanced practice nursing as evidenced by written protocols approved according to the requirements of Code of Ala. 1975, , et. seq. or exempted according to requirements of this statute. The term collaboration does not require direct, on-site supervision of the activities of a certified registered nurse practitioner or a certified nurse midwife by the collaborating physician. The term does require such medical oversight and direction as required by the rules and Supp. 3/31/17 8-3

4 Chapter 540-X-8 Medical Examiner regulations of the Board of Nursing and the State Board of Medical Examiners. (6) PHYSICIAN OR COLLABORATING PHYSICIAN. A doctor of medicine or a doctor of osteopathy licensed to practice medicine in Alabama who agrees in writing to practice in collaboration with one or more certified registered nurse practitioners or certified nurse midwives according to the rules an regulations adopted by the Board of Nursing and the State Board of Medical Examiners. (7) JOINT COMMITTEE OF THE BOARD OF NURSING AND THE STATE BOARD OF MEDICAL EXAMINERS FOR ADVANCED PRACTICE NURSES. The Joint Committee of the Board of Nursing and the State Board of Medical Examiners for Advanced Practice Nurses is a committee composed of the following, pursuant to Code of Ala. 1975, et seq. (a) Two physicians licensed to practice medicine in the State of Alabama; (b) One registered nurse licensed to practice professional nursing in the State of Alabama; (c) One licensed physician engaged in collaborative practice with a certified registered nurse practitioner or a certified nurse midwife in the State of Alabama; (d) One certified registered nurse practitioner engaged in advanced practice nursing with a physician in the State of Alabama; and (e) One certified nurse midwife engaged in advanced practice with a physician in the State of Alabama. (8) LEGEND DRUG. Any drug, medicine, chemical or poison bearing on the label the words, Caution, federal law prohibits dispensing without prescription or similar words indicating that such drug, medicine, chemical, or poison may be sold or dispensed only upon the prescription of a licensed practitioner, except that the term legend drug will not include any drug, substance, or compound which is listed Schedules I through V of the Alabama Uniform Controlled Substances Act. (9) PRESCRIBE OR PRESCRIBING. The act of issuing a prescription for a legend drug. (10) PRESCRIPTION. An order for a legend drug which is issued and signed by a practitioner authorized by law to Supp. 3/31/17 8-4

5 Medical Examiners Chapter 540-X-8 prescribe and administer such drugs and is intended to be filled, compounded, or dispensed by a pharmacist. (11) PROTOCOL. A document approved according to Code of Ala. 1975, , establishing the permissible functions and activities to be performed by certified registered nurse practitioners and certified nurse midwives and signed by collaborating physicians and any nurse practitioners or nurse midwives practicing with those physicians. (12) MEDICAL OVERSIGHT. Concurrent and on-going collaboration between a physician and a CRNP or CNM and documentation of time together in a practice site; may include but is not limited to direct consultation and patient care, discussion of disease processes and medical care, review of patient records, protocols and outcome indicators, and other activities to promote positive patient outcomes. (13) QUALITY ASSURANCE. Documented evaluation of the clinical practice of the certified registered nurse practitioner or certified nurse midwife against defined quality outcome measures, using a selected, meaningful sample of patient records which will identify areas needing improvement, set performance goals, and assess progress towards meeting established goals, with a summary of findings, conclusions, and, if indicated, recommendations for change. The physician s signature on the patient record does not constitute quality improvement monitoring. (14) PRINCIPAL PRACTICE SITE. The main location at which the collaborating physician is engaged in the practice of medicine. (15) REMOTE PRACTICE SITE. An approved site for collaborative practice without a collaborative or covering physician on-site. The collaborating physician s principal practice site, acute care hospitals, skilled nursing facilities, licensed, special-care assisted living facilities and licensed assisted living facilities are not remote practice sites for the purpose of these rules. (16) READILY AVAILABLE. Response by the collaborating or covering physician by telephone, telecommunication or radio for consultation, referral or direct medical intervention for a patient as indicated by the needs of a patient and based on usual and customary standards of medical practice. (17) DIRECT MEDICAL INTERVENTION. Physical presence of a physician to attend the patient as defined in the collaborative practice protocol. Supp. 3/31/17 8-5

6 Chapter 540-X-8 Medical Examiner Author: Alabama Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , History: Filed November 9, 1982 as Rule No. 540-X Readopted: Filed February 8, Rules reorganized --rule number changed to 540-X (see conversion table at end of code): Filed June 14, 1984 (without publication in AAM). Repealed: Filed June 20, 1996; effective July 26, New Rule: Filed June 20, 1996; effective July 26, Amended: Filed August 25, 2003; effective September 29, Amended: Filed October 6, 2006; effective November 10, Amended: Filed July 2, 2015; effective August 6, X Terms And Functions Of The Joint Committee. (1) The registered nurse members of the Joint Committee shall be appointed to three year terms by the Board of Nursing in accordance with Code of Ala. 1975, et. seq. (2) The physician members of the Joint committee shall be appointed to three year terms by the Board of Medical Examiners in accordance with Code of Ala. 1975, Section , et. Seq. (3) Terms of Joint Committee members shall begin October 1. (4) Joint Committee members may be reappointed to one additional term of three years by the respective board. (5) There shall be a minimum of four Joint Committee members with two representatives from each appointing Board present at a meeting to constitute a quorum for voting. (6) The Joint Committee shall have the authority to perform the following functions: (a) Recommend to the Board of Nursing and Board of Medical Examiners rules and regulations governing the collaborative relationship between physicians and certified registered nurse practitioners and certified nurse midwives engaging in advanced practice nursing. (b) Recommend to the Board of Nursing and Board of Medical Examiners model practice protocols to be used by the certified registered nurse practitioner and certified nurse midwife. Supp. 3/31/17 8-6

7 Medical Examiners Chapter 540-X-8 (c) Recommend to the Board of Nursing and Board of Medical Examiners a formulary of legend drugs that may be prescribed by a certified registered nurse practitioner and certified nurse midwife. (d) Perform other duties as directed by the Board of Nursing and Board of Medical Examiners. Author: Patricia E. Shaner, Attorney for the Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , , , History: Filed November 9, 1982 as Rule No. 540-X Readopted: Filed February 8, Rules reorganized--rule number change to 540-X (see conversion table at end of code): Filed June 14, 1984 (without publication in AAM). Repealed: Filed June 20, 1996; effective July 26, New Rule: Filed June 20, 1996; effective July 25, Amended: Filed August 25, 2003; effective September 29, X Qualifications For Approval To Practice As A Certified Nurse Practitioner. (1) The applicant for approval to practice as a certified registered nurse practitioner shall have: (a) An active Alabama registered nurse license. Initial applicants shall have an unencumbered active Alabama registered nurse license unless authorized by the Board of Nursing. (b) Met all requirements for completion of or graduation from an organized program of study and clinical experience beyond the basic educational preparation as a registered nurse, that prepares nurse practitioners and is recognized by the Board of Nursing and the appropriate specialty certifying agency. (c) At least a master s or higher degree in advanced practice nursing from an accredited program recognized by the Board of Nursing. (d) Current certification as a certified registered nurse practitioner granted by a national certifying agency recognized by the Board of Nursing in the clinical specialty consistent with educational preparation and appropriate to the area of practice. Supp. 3/31/17 8-7

8 Chapter 540-X-8 Medical Examiner (2) The applicant for initial approval as a certified registered nurse practitioner who meets one of the following criteria is exempt from the requirement for a master s degree in nursing: (a) Graduation prior to 1996 from a Board of Nursing-recognized post-baccalaureate program preparing nurse practitioners. (b) Graduation prior to 1984 from a non-baccalaureate program preparing nurse practitioners. (3) The Board of Nursing may grant a waiver of the master s degree requirement at its discretion. Author: Patricia E. Shaner, Attorney for the Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , History: Filed November 9, 1982 as Rule No. 540-X Readopted: Filed February Rules reorganized--rule number changed to 540-X (see conversion table at end of code): Filed June 14, 1984 (without publication in AAM). Repealed: Filed June 20, 1996; effective July 26, New Rule: Filed June 20, 1996; effective July 26, Repealed and New Rule: Filed August 25, 2003; effective September 29, X Qualifications For Physicians In Collaborative Practice With Certified Registered Nurse Practitioners. (1) The physician in collaborative practice with a certified registered nurse practitioner shall have: (a) A current, unrestricted license to practice medicine in the State of Alabama; and (b) Practiced medicine for at least one year, if the physician is certified by or eligible for board certification by a specialty board approved by the American Medical Association or by the American Osteopathic Association; or have practiced medicine for at least three years. (c) Paid all collaborative practice fees due to the Board of Medical Examiners and submitted to the Board of Medical Examiners a Commencement of Collaborative Practice form. In the event no application is received from the Alabama Board of Nursing within six (6) months of submission, the submitted form will be withdrawn by the Board. The fee submitted with the Supp. 3/31/17 8-8

9 Medical Examiners Chapter 540-X-8 Commencement of Collaborative Practice form is non-refundable and non-transferable. (2) The Board of Medical Examiners, in its discretion, may waive the practice requirements in 1(b). (3) The physician shall not collaborate with or supervise any combination of certified registered nurse practitioners, certified nurse midwives and/or assistants to physicians exceeding one hundred and sixty (160) hours per week (four full-time equivalent positions) unless an exemption is granted under Rule 540-X One full-time equivalent (FTE) is herein described as a person/persons collectively working forty hours a week, excluding time on call. (4) A physician entering into a collaborative practice arrangement with a certified registered nurse practitioner, including those who have been granted temporary approval to practice as a certified registered nurse practitioner under the provisions of Rule 540-X-8-.07, shall notify the State Board of Medical Examiners in writing of the following: (a) The date for commencement of the collaborative practice agreement using the Commencement of Collaborative Practice form. The Collaborative Practice Fee must accompany the Commencement of Collaborative Practice form. (b) The date on which the collaborative practice agreement between the collaborating physician and the nurse practitioner terminates. The "Notice of Termination" should be submitted within fourteen (14) days of the date of termination. The "Notice of Termination" shall be authorized by the collaborating physician and should include the name and license number of the collaborating physician and the name and license number of the Certified Registered Nurse Practitioner. Author: Alabama Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , History: Filed November 9, 1982 as Rule No. 540-X Readopted: Filed February 8, Rules reorganized--rule number change to 540-X (see conversion table at end of code): Filed June 14, 1984 (without publication in AAM). Repealed: Filed June 20, 1996; effective July 26, New Rule: Filed June 20, 1996; effective July 26, Amended: Filed August 25, 2003; effective September 29, Amended: Filed July 22, 2005; effective August 26, Amended: Filed November 13, 2007; effective December 18, Amended: Filed July 2, 2015; effective August 6, Amended: Filed February 16, 2017; effective March 2, Supp. 3/31/17 8-9

10 Chapter 540-X-8 Medical Examiner 540-X Application And Approval To Practice As A Certified Registered Nurse Practitioner. (1) The applicant for approval to practice as a certified registered nurse practitioner shall submit to the Nursing Board: (a) The required fee(s) and a completed application including the standard protocol to be followed by the certified registered nurse practitioner and each collaborating physician, unless application is made for an exemption from a collaborative practice agreement pursuant to Rule 540-X (b) An official transcript of education for advanced practice nursing as a nurse practitioner that indicates the date of completion of the program and the date degree or certificate was conferred if the dates are not the same. (c) Official evidence of current certification as a nurse practitioner by the respective specialty certifying agency appropriate to the applicant s education, preparation, proposed clinical area of practice, and proposed collaborating physician s area of practice. (2) The Board of Nursing may decline to consider an applicant who is under investigation for a potential violation of the Code of Alabama, 1975, Section and the Alabama Board of Nursing Administrative Code, Chapter 610-X-8. Author: Patricia E Shaner, Attorney for the Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , , History: Filed November 9, 1982 as Rule No. 540-X Readopted: Filed February 8, Rules reorganized--rule number change to 540-X (see conversion table at end of code): Filed June 14, 1984 (without publication in AAM). Repealed: Filed June 20, 1996; effective July 26, New Rule: Filed June 20, 1996; effective July 26, Repealed and New Rule: Filed August 25, 2003; effective September 29, X Authorization For Practice As A Certified Registered Nurse Practitioner. Supp. 3/31/

11 Medical Examiners Chapter 540-X-8 (1) The Board of Nursing may grant a certificate of qualification for advanced practice nursing as a certified registered nurse practitioner to applicants who meet the requirements of 540-X (2) Only those registered nurses who have been issued a certificate of qualification by the Board of Nursing and have current approval for collaborative practice from the Board of Nursing and the Board of Medical Examiners may hold themselves out to be certified registered nurse practitioners, use the designation CRNP, or use titles to imply that they are certified registered nurse practitioners. Prior to approval as a Certified registered nurse practitioner, the registered nurse may use only the designation or title granted by the specialty certifying agency. (3) When for any reason the collaborative practice agreement with the physician designated in the application for approval is terminated, then approval of such certified registered nurse practitioner and collaborating physician designated in the application is automatically withdrawn. (a) The certified registered nurse practitioner and the physician shall each inform their respective board in writing of the effective date of the termination of the collaborative practice agreement and the reasons for such termination. Failure to notify the respective board of termination may be considered a violation of these rules and regulations. (b) The certified registered nurse practitioner shall notify the Board of Nursing using the on-line form Terminate an Existing Collaboration. (4) The advanced practice approval shall expire prior to the RN license if the nurse practitioner national specialty certification expires during the license period. (5) Approval for advanced practice may be continued each biennium at the time of renewal of the registered nurse license upon verification of: (a) Meeting the requirements of Rule 540-X (b) Continued collaboration with the approved physician(s) or eligibility for continued exemption from collaboration. (c) Payment of the advanced practice renewal fee. Supp. 3/31/

12 Chapter 540-X-8 Medical Examiner (6) Failure to meet the requirements for renewal shall result in lapse of the advanced practice approval. (7) A nurse who fails to attain or maintain specialty certification as a nurse practitioner from a specialty certification agency shall: (a) Immediately notify the Board of Nursing. (b) Not practice as or use the title of certified registered nurse practitioner until approved by the Board of Nursing. (8) The registered nurse who has been issued a certificate of qualification as a certified registered nurse practitioner from the Board of Nursing may use the designation specific to the authorization, as follows: (a) CRNP - Faculty. The registered nurse who: 1. Meets all qualifications for approval as a certified registered nurse practitioner as provided in Rule 540-X Holds a teaching position in a nurse practitioner education program recognized by the Alabama Board of Nursing. 3. Has made application for approval with the exception of the protocol for the Certified registered nurse practitioner and physician as provided in Rule 540-X Requests approval as a certified registered nurse practitioner without prescriptive authority in order to supervise nurse practitioner students in direct care of patients in clinical settings where there is a Certified registered nurse practitioner in an approved collaborative practice or a physician who is present to oversee patient care. (b) CRNP - Federal Only The registered nurse who: 1. Meets all qualifications for approval as a certified registered nurse practitioner as provided in Rule 540-X Is employed by the United States government. 3. Requests an exemption from collaborative practice with a physician licensed to practice medicine in Alabama. Supp. 3/31/

13 Medical Examiners Chapter 540-X-8 4. Is authorized for practice with prescriptive authority under established federal regulations and guidelines limited to the employing federal agency. Author: Alabama Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , , History: New Rule: Filed August 25, 2003; effective September 29, Amended: Filed July 2, 2015; effective August 6, Amended: Filed July 21, 2016; effective September 4, X Temporary Approval To Practice As A Certified Registered Nurse Practitioner. (1) The applicant for approval to practice as a certified registered nurse practitioner may be granted temporary approval for practice under the following stipulations until such time as the application is approved or denied by the Board of Nursing and the Board of Medical Examiners. (a) The applicant shall meet the requirements of Rules 540-X and 540-X (b) The collaborating physician shall meet the qualifications established in Rule 540-X (c) Temporary approval is limited to the standard protocol and formulary approved by the Joint Committee of the Alabama Board of Nursing and the Board of Medical Examiners and does not include the authority to: 1. Perform additional skills as provided in Rule 540-X Prescribe drugs that are listed in the standard formulary with Restrictions. (2) Provisional approval: A registered nurse who meets the requirements of Rules 540-X and 540-X with the exception of national certification, and who has applied for initial certification may be granted temporary approval under paragraph (1)(c) of this rule with these additional stipulations. (a) Practice under the on-site supervision of an approved certified registered nurse practitioner or a licensed physician. Supp. 3/31/

14 Chapter 540-X-8 Medical Examiner (b) During the period of provisional approval, there shall be one hundred percent review of patient cases by the collaborating physician. (c) The nurse practitioner with provisional approval may use the designation Graduate Registered Nurse Practitioner. (d) Provisional approval to practice is limited to a maximum of six months and shall expire immediately upon: 1. Notification of approval by the Board of Nursing. 2. Notification of failure of the certification examination. (3) Interim: If the relationship with the collaborating physician is terminated, a certified registered nurse practitioner approved to practice under the provisions of these rules may continue in a collaborative practice with an interim physician after application for approval until such time as the new application is approved or denied, provided the interim physician meets the qualifications established in Rule 540-X Author: Alabama Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , , History: New Rule: Filed June 20, 1996; effective July 26, Repealed and New Rule: Filed August 25, 2003; effective September 29, Amended: Filed July 2, 2015; effective August 6, X Requirements For Collaborative Practice By Physicians And Certified Registered Nurse Practitioners. (1) The collaborating physician shall: (a) Provide professional medical oversight and direction to the certified registered nurse practitioner. (b) Be readily available for direct communication or by radio, telephone or telecommunications. (c) Be readily available for consultation or referrals of patients from the certified registered nurse practitioner. (2) In the event the collaborating physician is not readily available, provisions shall be made for medical coverage Supp. 3/31/

15 Medical Examiners Chapter 540-X-8 by a physician who is pre-approved by the Board of Medical Examiners and is familiar with these rules. (3) The certified registered nurse practitioner's scheduled hours in patient homes, and/or facilities licensed by the Alabama Department of Public Health and facilities certified by the Alabama Department of Mental Health are not subject to the required minimum hours for physician presence. (4) The Collaborating Physician shall: (a) Have no additional requirement for documentation of on-site collaboration when working in the same facility with the Certified Registered Nurse Practitioner (CRNP). (b) Be present for not less than ten percent (10%) of the CRNP s scheduled hours in an approved practice site with a CRNP who has less than two (2) years (4,000 hours) of collaborative practice experience: 1. Since initial certification; or 2. In the collaborating physician s practice specialty. (c) annually. Visit remote practice sites no less than twice (d) Meet no less than quarterly with the CRNP who has more than two (2) years (4,000 hours) of collaborative practice experience. (e) Allow a pre-approved covering physician to be present in lieu of the collaborating physician. (5) The collaborating physician shall provide notice in writing to the State Board of Medical Examiners of the commencement or termination of a collaborative practice agreement as required by Rule 540-X (6) The Joint Committee may, at its discretion, waive the requirements of written verification of physician availability upon documentation of exceptional circumstances. Employees of state and county health departments are exempt from the requirements of written verification of physician availability. (7) A written standard protocol specific to the specialty practice area of the certified registered nurse practitioner and the specialty practice area of the collaborating Supp. 3/31/

16 Chapter 540-X-8 Medical Examiner physician, approved and signed by both the collaborating physician and the certified registered nurse practitioner shall: (a) Identify all sites where the certified registered nurse practitioner will practice within the collaboration protocol. (b) (c) Identify the physician's principal practice site. Be maintained at each practice site. (d) Include a formulary of drugs, devices, medical treatments, tests and procedures that may be prescribed, ordered, and implemented by the certified registered nurse practitioner consistent with these rules and which are appropriate for the collaborative practice setting. (e) services. Include a pre-determined plan for emergency (f) Specify the process by which the certified registered nurse practitioner shall refer a patient to a physician other than the collaborating physician. (g) Specify a plan for quality assurance management with defined quality outcome measures for evaluation of the clinical practice of the certified registered nurse practitioner and include review of a meaningful sample of medical records plus all adverse outcomes. The term "medical records" includes, but is not limited to, electronic medical records. Documentation of quality assurance review shall be readily retrievable, identify records that were selected for review, include a summary of findings, conclusions, and, if indicated, recommendations for change. Quality assurance monitoring may be performed by designated personnel, with final results presented to the physician and certified registered nurse practitioner for review. Author: Alabama Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , History: New Rule: Filed June 20, 1996; effective July 26, Repealed and New Rule: Filed August 25, 2003; effective September 29, Amended: Filed July 22, 2005; effective August 26, Amended: Filed October 6, 2006; effective November 10, Amended: Filed February 21, 2008; effective March 27, Amended: Filed March 11, 2010; effective April 15, Amended: Filed September 24, 2012; effective October 29, Amended: Filed July 2, 2015; effective August 6, Supp. 3/31/

17 Medical Examiners Chapter 540-X-8 Ed. Note: Was previously Rule 540-X-8-.09, renumbered as per certification filed August 25, 2003; effective September 29, X Standards Of Practice For Certified Registered Nurse Practitioners. The certified registered nurse practitioner shall practice in accordance with national standards and functions identified by the appropriate specialty-certifying agency as recognized by the Board of Nursing and as congruent with Alabama law. Author: Patricia E. Shaner, Attorney for the Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , History: New Rule: Filed August 25, 2003; effective September 29, X Functions And Activities Of Certified Registered Nurse Practitioners. (1) The certified registered nurse practitioner is responsible and accountable for the continuous and comprehensive management of a broad range of health services for which the certified registered nurse practitioner is educationally prepared and for which competency is maintained, with physician collaboration as described in these rules. These services include but are not restricted to the following: (a) Evaluate current health status and risk factors of individuals based on comprehensive health history and comprehensive physical examinations and assessments. (b) Formulate a working diagnosis, develop and implement a treatment plan, and evaluate/modify therapeutic regimens to promote positive patient outcomes. (c) Prescribe, administer and provide therapeutic measures, tests, procedures, and drugs. (d) Counsel, teach and assist individuals/families to assume responsibility for self-care in prevention of illness, health maintenance, and health restoration. (e) Consult with refer to other health care providers as appropriate. Supp. 3/31/

18 Chapter 540-X-8 Medical Examiner (2) A standard protocol approved by the Board of Nursing and Board of Medical Examiners shall address permissible functions and activities specific to the advanced practice of the certified registered nurse practitioner. (3) A certified registered nurse practitioner may, after the successful completion of an organized program of study and supervised clinical practice, carry out functions beyond the nurse practitioner educational preparation provided the functions are approved by the Board of Nursing as being within the legal scope of practice for a certified registered nurse practitioner. Such functions will be submitted to the Joint Committee for consideration for inclusion on the standard protocol. (4) Requests for additional functions to be added to the protocol may be submitted to the Joint Committee for consideration. (5) A certified registered nurse practitioner may write admission orders for inpatients as directed by the physician and subsequent orders in accordance with established protocols and institutional policies. Author: Patricia E. Shaner, Attorney for the Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , , History: New Rule: Filed June 20, 1996; effective July 26, Amended: Filed August 25, 2003; effective September 29, Amended: Filed September 11, 2008; effective October 16, X Prescriptions And Medication Orders By Certified Registered Nurse Practitioners. (1) Certified registered nurse practitioners engaged in collaborative practice with physicians may be granted prescriptive authority upon submission of evidence of completion of an academic course in pharmacology or evidence of integration of pharmacology theory and clinical application in the certified registered nurse practitioner curriculum. (2) Certified registered nurse practitioners practicing under protocols approved in the manner prescribed by Code of Ala. 1975, et seq. may prescribe legend drugs to their patients, subject to the following conditions: Supp. 3/31/

19 Medical Examiners Chapter 540-X-8 (a) The drug shall be included in the formulary recommended by the Joint Committee and adopted by the Board of Nursing and the State Board of Medical Examiners. (b) The drug type, dosage, quantity prescribed, and number of refills shall be authorized in an approved protocol signed by the collaborating physician and the certified registered nurse practitioner. This requirement may be met if written prescriptions adhere to the standard recommended dosages of legend drugs as identified in the Physicians Desk Reference or Product Information Insert, and do not: 1. Exceed the recommended treatment regimen periods. 2. Include United States Food and Drug Administration (FDA) non-approved supplements, drug products, medication, and off label medications. (c) Drugs and medications that do not have FDA approval may be prescribed through protocol registration in a United States Institutional Review Board or Expanded Access authorized clinical trial. (d) Off label use or prescription of FDA-approved medications for uses other than that indicated by the FDA is permitted when such practices are: 1. Within the current standard of care for treatment of disease or condition. 2. Supported by evidence-based research. 3. Approved by the collaborating physician and entered into the patient record. (3) A certified registered nurse practitioner may not initiate a call-in prescription in the name of a collaborating physician for any drug, whether legend or controlled substance, which the certified registered nurse practitioner is not authorized to prescribe under the protocol signed by the collaborating physician and certified registered nurse practitioner and approved under this section unless the drug is specifically ordered for the patient by the physician, either in writing or by a verbal order which has been transcribed in writing, and which has been signed by the physician within seven working days or as otherwise specified by the Board of Nursing and the Board of Medical Examiners. (4) A written prescription for any drug that the certified registered nurse practitioner is authorized to Supp. 3/31/

20 Chapter 540-X-8 Medical Examiner prescribe may be called in to a pharmacy, provided the prescription is entered into the patient s record and signed by the certified registered nurse practitioner. (5) The certified registered nurse practitioner in collaborative practice with prescriptive privileges shall not engage in prescribing for: (a) (b) Self. Immediate family members. (c) Individuals who are not patients of the practice, except in cases, where a certified registered nurse practitioner is prescribing for the sexual partner(s) of a patient in accordance with an Expedited Partner Therapy (EPT) protocol for the prevention of transmission and spread of sexually transmitted disease(s). (6) The certified registered nurse practitioner who is in collaborative practice and has prescriptive privileges may receive and sign for samples of legend drugs that are authorized in the approved formulary for the collaborative practice, provided the certified registered nurse practitioner complies with all applicable state and federal laws and regulations. (7) When prescribing legend drugs a certified registered nurse practitioner shall use a prescription form which includes all of the following: (a) The name, medical practice site address and telephone number of the collaborating physician or covering physician; (b) The certified registered nurse practitioner s name printed below or to the side of the physician s name; (c) The medical practice site address and telephone number of the certified registered nurse practitioner if different from that of the collaborating physician; (d) The certified registered nurse practitioner s registered nurse license number and identifying prescriptive authority number assigned by the Board of Nursing; (e) The words Product Selection Permitted printed on one side of the prescription form directly beneath a signature line; Supp. 3/31/

21 Medical Examiners Chapter 540-X-8 (f) The words Dispense as written printed on one side of the prescription form directly beneath a signature line. (g) The date that the prescription is issued to the patient. Author: Alabama Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , History: New Rule: Filed June 20, 1996; effective July 26, Amended: Filed August 25, 2003; effective September 29, Amended: Filed July 2, 2015; effective August 6, Amended: Filed October 20, 2016; effective December 4, X Limitations Upon Utilization Of Certified Registered Nurse Practitioners. (1) A physician may enter into collaborative agreements with certified registered nurse practitioners not exceeding a cumulative one hundred and sixty (160) hours (four FTEs) per week. The total number of persons supervised by or in collaborative practice with a physician shall not exceed one hundred and sixty (160) hours per week (four full-time equivalent positions) as stipulated in Rule 540-X (2) Employees of the Alabama Department of Public Health and county health departments are specifically exempt from the requirements of paragraph (1) of this rule. (3) A physician in collaborative practice may request approval for additional full-time certified registered nurse practitioner positions by the Joint Committee, with consideration given to the following factors to insure that an acceptable standard of care is rendered: (a) availability of the physician (b) practice settings and staffing needs for extended hours of service (c) risk to patients (d) educational preparation, specialty and experience of the parties in the collaborative practice (e) complexity and risk of procedures to be performed. Supp. 3/31/

22 Chapter 540-X-8 Medical Examiner (4) Any certified registered nurse practitioners engaged in practice with a collaborating physician prior to June 26, 1995, may not be denied approval for continued collaborative practice with that physician based on the ratio established in Rule 540-X-8-.12(1). (5) A physician in collaboration with CRNP, CNM or Physician Assistant personnel totaling 160 hours per week (four (4) FTEs) may request a transitional allowance increasing the total weekly hours for the purpose of orientation of the incoming CRNP. The transitional allowance shall not exceed 45 days. The physician shall request the transitional allowance in writing and specify the starting date for this FTE allowance. Author: Patricia E. Shaner, Attorney for the Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , History: New Rule: Filed June 20, 1996; effective July 26, Amended: Filed August 25, 2003; effective September 29, Amended: Filed July 22, 2005; effective August 26, Amended: Filed July 2, 2015; effective August 6, X Grounds For Denial/Withdrawal Of Approval Of The Certified Registered Nurse Practitioner And Collaborating Physician. (1) The commission by a certified registered nurse practitioner of any act, offense, or condition set forth in Code of Ala. 1975, and/or Board of Nursing Administrative Code Rule 610-X-8 and/or the commission by the collaborating physician of any act, offense or condition set forth in Code of Ala. 1975, and , shall be grounds, within the discretion of the respective board, to deny an application of the certified registered nurse practitioner or collaborating physician. (2) If upon examination of the application for approval and after consideration of any information acquired by the Board of Nursing and/or the Board of Medical Examiners pursuant to an investigation into the qualifications of the physician or of the certified registered nurse practitioner, either board determines there is probable cause to believe there exists one or more grounds upon which the application may be denied, then the respective board shall: (a) Notify the physician and/or the certified registered nurse practitioner of the grounds for possible denial of approval and the procedure for obtaining a hearing before the Supp. 3/31/

23 Medical Examiners Chapter 540-X-8 respective board. The failure to request a hearing within the time specified in the notice shall be deemed a waiver of such hearing. (b) All hearings under this rule shall be conducted in accordance with the Code of Ala. 1975, Alabama Administrative Procedure Act, , et. seq. (3) A nurse practitioner who is decertified by the appropriate national certifying organization shall notify the Board of Nursing of that fact and shall not practice or use the title of certified registered nurse practitioner during the time of de-certification. (4) When for any reason the collaborative practice agreement with the physician designated in the application for approval is terminated, then approval of such certified registered nurse practitioner and collaborating physician designated in the application is automatically withdrawn. The certified registered nurse practitioner and the physician shall each inform their respective board in writing of the effective date of the termination of the collaborative practice agreement and the reasons for such termination. Failure to notify the respective board of termination may be considered a violation of these rules and regulations for the purpose of approval of future applications. Author: Patricia E. Shaner, Attorney for the Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , History: Filed November 9, 1982 as Rule No. 540-X Readopted: Filed February 8, Rules reorganized--rule number changed to 540-X (see conversion table at end of code): Filed June 14, 1984 (without publication in AAM). Repealed: Filed June 20, 1996; effective July 26, New Rule: Filed June 20, 1996; effective July 26, Amended: Filed August 25, 2003; effective September 29, Ed. Note: Was previously Rule 540-X-8-.06, renumbered as per certification filed August 25, 2003; effective September 29, X Denial, Suspension And Revocation Of License. (1) The Board of Nursing may deny, suspend or revoke the license of a certified registered nurse practitioner for any cause set forth in Code of Ala. 1975, , and any rules promulgated pursuant to law. Supp. 3/31/

24 Chapter 540-X-8 Medical Examiner (2) The Board of Medical Examiners may seek the denial, suspension or revocation of the license of a physician for any cause set forth in Code of Ala. 1975, as amended, and and any rules promulgated pursuant to law. (3) A CRNP who is denied a license or whose license is suspended or revoked may appeal to the Circuit Court or a court of like jurisdiction of the county in which said person resides, any order of the respective board under this section within thirty days from date of decision of the board. The trial of appeals hereunder shall be conducted in like manner, as nearly as may be, as provided for in Code of Ala. 1975, as amended, (4) A physician who is denied a license or whose license is suspended or revoked may appeal to the Alabama Court of Civil Appeals according to Code of Ala. 1975, as amended, Author: Patricia E. Shaner, Attorney for the Board of Medical Examiners Statutory Authority: Code of Ala. 1975, , , , , , History: New Rule: Filed June 20, 1996; effective July 26, Amended: Filed August 25, 2003; effective September 29, Amended: Filed July 2, 2015; effective August 6, Ed. Note: Was previously Rule 540-X-8-.13, renumbered as per certification filed August 25, 2003; effective September 29, X Grounds For Termination Of Approval Of A Collaborative Practice - Physicians And Certified Registered Nurse Practitioners. (1) The following acts shall constitute grounds for the termination of the approval of the State Board of Medical Examiners of the collaborating practice of a physician and a certified registered nurse practitioner: (a) Prescribing in violation of through of the Code of Ala or the rules of the State Board of Medical Examiners. Supp. 3/31/

25 Medical Examiners Chapter 540-X-8 (b) For a physician to require or to knowingly permit or condone a certified registered nurse practitioner to engage in any act or render any services not authorized in his or her protocol. (c) Failure of a physician to maintain current licensure with the Medical Licensure Commission of Alabama. (d) The commission of any act by a physician which would constitute a violation of of the Code of Ala Author: Patricia E. Shaner, Attorney for the Board of Medical Examiners. Statutory Authority: Code of Ala. 1975, , History: New Rule: Filed April 23, 2004; effective May 28, X Termination Of Approval Of A Collaborative Practice - Physicians And Certified Registered Nurse Practitioners. (1) Before terminating the approval of the State Board of Medical Examiners of a collaborating practice of a physician and a certified registered nurse practitioner on any of the grounds specified in this Chapter, the State Board of Medical Examiners shall conduct a hearing under the provisions of the Alabama Administrative Procedure Act, through of the Code of Ala. 1975, and Chapter 6 of the rules of the State Board of Medical Examiners. (2) Pursuant to the requirements of (d) of the Code of Ala. 1975, the State Board of Medical Examiners may order the summary suspension of the Board s approval of the collaborating practice of a physician and a certified registered nurse practitioner for any of the reasons stated in of the Code of Ala. 1975, and Alabama Board of Medical Examiners Rule 540-X if the Board finds that danger to the public health, safety or welfare requires the emergency suspension. (3) An order of summary suspension of the Board s approval of a collaborating practice of a physician and a certified registered nurse practitioner shall become effective immediately, unless otherwise stated in the order. Simultaneously with the issuance of an order of summary suspension, a proceeding for a hearing shall be instituted. The suspension may be effective for a period of not longer than one hundred and twenty (120) days. Supp. 3/31/

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